Rezulin Side Effects

Rezulin Side Effects

Heart Damage Another Cover-up?
In the first 18 months of sales, FDA records showed 56 reports of Rezulin side effects leading to heart failure.

Approved on the fast track in 1997, Rezulin side effects now links to at least 56 cases of heart failure and 90 cases of liver failure ended up sparking a debate over Congress’ demand for speedy reviews of new prescription drugs.

Previously undisclosed documents and interviews showed that heart defects were also a Rezulin side effects concern from the beginning.

Rezulin was FDA approved in just six months, which did not allow a complete clinical trial to determine if Rezulin side effects caused heart damage. Instead, the Echo Study was put together to determine whether the use of Rezulin for 48 weeks would result in a change in the left ventricle.

A left ventricle change would indicate heart failure because it can result if it cannot contract forcefully enough. Read More about Rezulin Side Effects…

 

 

 

When Rezulin was approved in January 1997, Warner-Lambert downplayed the liver damage complications claiming that Rezulin side effects were low risk. As early as 1993, the manufacturer knew that at least 12 people had suffered from Rezulin side effects causing liver damage. Despite the consumer advocacy group, Public Citizen’s, attempts to have Rezulin recalled as early as July 1998, the diabetes drug remained on the market until March 21, 2000. By this time there were 90 reported cases of Rezulin side effects of liver failure that had led to the deaths of 63 people.

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from liver failure and thousands of other liver damage cases from 1997-2000. Contact us to speak directly with an expert Rezulin side effects lawyer.

Breaking News!!
Pfizer Must Defend Rezulin Lawsuit

April 22, 2003 - An appeal court reinstated a Rezulin lawsuit that was dismissed in October 2001 in a lower court. The Rezulin lawsuit alleged that Pfizer’s Warner-Lambert unit hid Rezulin safety risks and continued to aggressively market Rezulin despite the serious liver damages being reported. Rezulin class action lawsuit status is currently being sought for the damages suffered by Rezulin patients.

Rezulin Recalled

“I’m astonished that the additional year of product (Rezulin) life even existed.”

-Jerry Avorn, chief of the division tracking adverse medication events at Brigham and Women’s Hospital in Boston, (USA Today, 5-3-00)

Rezulin was recalled on March 21, 2000 after the Rezulin side effects were shown to cause death and serious injuries to the liver and to the heart. Around two million people have used Rezulin and about 500,000 Americans were using Rezulin at the time of the recall. Public Citizen had been petitioning the FDA since July 1998 for the immediate ban of the drug because of the Rezulin side effects of liver problems.

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from liver failure and thousands of other liver damage cases from 1997-2000.

Deaths Linked to Rezulin Side Effects
Rezulin was recalled on March 21, 2000. There were 90 cases of liver failures attributed to Rezulin side effects. The actual number of fatalities is expected to be much greater due to the large number of underreporting that is estimated account for just 1-10% according to experts. Of the reported 90 Rezulin side effects cases of liver failure there were:

  • 63 deaths

  • 7 liver transplant survivors

  • 10 recoveries without a liver transplant

  • 10 people continuing to suffer from liver failure





Short Cut Led to Rezulin Death and Serious Injuries
Every year there is an estimated two million drug-related hospitalizations a year, including tens of thousands of deaths. Rezulin’s “breakthrough” status allowed it to speed through FDA approval in just six months, but why are major risks being allowed when serious and deadly Rezulin side effects are associated to the drug?

More and more drugs are fast tracked by the FDA that requires very strict guidelines. Rezulin was quickly approved but required detailed and regular monitoring of a patient’s liver. Due to the FDA’s four attempts to strengthen Rezulin labels to make liver testing more frequent, far fewer than 10% of patients received the recommended 1997 monthly liver function tests according to the FDA.



Liver Failure Rezulin Risk

>
Dr. David J. Graham, who is regarded as the FDA's top expert in assessing and preventing deaths related to the use of prescription drugs, concluded that Rezulin side effects sare 1200 times more likely to suffer liver failure.

> Graham noted that at least 430 Rezulin side effects patients had suffered liver failure, most resulting in death or organ transplant.


Critics
say FDA approves new drugs too quickly.


> Rezulin was approved on the “fast track” in just six months, a substantial decrease from the usual years it takes.

> The FDA has sped up due to congressional pressure, and average review time for new drugs was just 14.6 months in fiscal 2000, down from 34.3 months in 1993.

> The drugs that are seen as breakthroughs and whose drug makers can make special fees to the FDA can get the speedier six-month review.

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